A Study of QY101 Ointment in Subjects With Plaque Psoriasis

NCT06170840 | Unknown Phase 2

• 1 other identifier: QY101-Ⅱ-1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of QY101 ointment in adult patients with plaque psoriasis (2-20% BSA).

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Physician Global Assessment（PGA）response

  At week 8, the proportion of subjects in each trial group who responded to the Physician Global Assessment (PGA) compared to the placebo group. The PGA response was defined as a PGA score of 0 (clear) or 1 (nearly clear) and an improvement of ≥ 2 points from baseline on the PGA scale.

  8 weeks

Study Arms (3)

QY101 placebo ointment

PLACEBO COMPARATOR

40 subjects use QY101 placebo ointment twice daily for 12 weeks

Drug: QY101Placebo/QY101 ointment

0.3% QY101 ointment

EXPERIMENTAL

60 subjects use QY101 placebo ointment twice daily for 12 weeks

Drug: QY101Placebo/QY101 ointment

1.0 % QY101 ointment

EXPERIMENTAL

60 subjects use1.0 % QY101 ointment twice daily for 12 weeks

Drug: QY101Placebo/QY101 ointment

Interventions

QY101Placebo/QY101 ointment DRUG

External use for BID

0.3% QY101 ointment; 1.0 % QY101 ointment; QY101 placebo ointment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to understand and comply with the test process, voluntarily participate in the test and provide informed consent;
• When signing the informed consent, age ≤ 18 years old ≤ 75 years old, gender is not limited;
• The patient meets the diagnosis of plaque psoriasis, has a history of plaque psoriasis for ≥ 6 months before randomization, and meets the following conditions:
• At baseline, plaque psoriasis covered 2% to 20% of BSA (including both ends) (scalp, palms, and soles were not counted as BSA);
• Physician overall assessment (PGA) ≥ 2 at baseline;
• Fertile men and women of childbearing age must agree to use reliable contraception from the time they sign an informed consent until six months after the last dose of the investigational drug; Blood pregnancy tests for women of childbearing age must be negative during screening and at baseline.

You may not qualify if:

• Other types of psoriasis were diagnosed during screening, such as gutting psoriasis, erythrodermic psoriasis, generalized pustular psoriasis, arthropathic psoriasis, drug-induced or drug-aggravated psoriasis;
• The presence of other systemic autoimmune inflammatory diseases and skin lesions (such as eczema), which may affect the evaluation of treatment outcomes;
• Subjects who are expected to receive additional local therapy, phototherapy, or other systemic therapy other than investigational medication during the trial;
• Taking drugs that can aggravate psoriasis (such as lithium, antimalarial drugs, etc.);
• Patients who have failed or are intolerant to previous treatment with Phosphodiesterase-4 (PDE4) inhibitors;
• Known to be allergic to the study drug or related excipients (QY101 ointment and excipients: albuvarin, light liquid paraffin, propylene glycol, Carbonic acid, glyceryl behenate, glyceryl monodistearate, hydroxyphenyl butyl, propyl gallate and disodium edetate), or have a history of angioedema or allergy to topical drugs;
• receive contraindicated drugs, supplements, and other treatments prescribed in this trial that may affect the course of psoriasis within the specified time period prior to initial dosing or planned for the duration of the trial (see Appendix 2: Concomitant medications during the trial);
• Participants who are participating in another interventional clinical trial or whose last use of another investigational drug is less than 5 half-lives prior to the first dosing of the investigational drug;
• any history of infection or recurrent infection requiring systemic antibiotic treatment within 2 weeks prior to first dosing, or serious infection requiring hospitalization or intravenous antibiotic treatment within 8 weeks prior to first dosing (e.g., pneumonia, cellulitis, bone or joint infection, etc.); Recurrent, chronic, or other active infection at the time of initial dosing, if the investigator determines that participation in the study increases participants' risk;
• Use of a suppressant of CYP3A liver metabolic enzyme, or use of any medication, including prescription, over-the-counter, and herbal oral or topical drugs, other than vitamins and/or Paracetamol, within 2 weeks prior to initial administration;
• Participants who have received, or plan to receive, a live or attenuated vaccine within 4 weeks prior to initial administration;
• Abnormal laboratory test results during screening, including:
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or basic phosphoric acid
• Enzyme (ALP) \> 2.5 × Upper Limit of Normal (ULN);
• Serum creatinine \> 1.5×ULN, or creatinine clearance \< 50 mL/min.

Sponsors & Collaborators

• E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.: lead

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xiaoyong Man, Doctor

CONTACT

+86 1360051 6219; manxy@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: May 17, 2023
• Primary Completion: February 29, 2024
• Study Completion: April 30, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

CN (1)